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Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04010981
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : August 5, 2020
Sponsor:
Information provided by (Responsible Party):
Irmak ÇAVUŞOĞLU, Acibadem University

Brief Summary:
In this study, we aim to improve respiratory function and balance of decreased muscle strength, decrease fatigue values, improve quality of life, improve inflammation findings and GFR ( Glomerular filtration rate) values in pediatric chronic kidney patients with virtual reality exercise applications.

Condition or disease Intervention/treatment Phase
Pediatric Kidney Disease Physical Activity Exercise Addiction Other: study group Other: control group Not Applicable

Detailed Description:

1.Group - Working group: Virtual reality technology (Nintendo Wii Fit Plus) exercise group 2.Group-Control group: home-based video games will be divided into groups that exercise.

Measurements of functional capacity, muscle strength, quality of life, depression, fatigue and physical activity levels, medical values (pulmonary function test values, inflammation level values, glomerular filtration rate level values) of both groups will be recorded before and after treatment.

In the study group treatment protocol; patients will complete 12 sessions of virtual reality exercise application-Nintendo Wii Fit Plus 30-minute training sessions with strengthening exercises for the lower extremities and upper extremities, aerobic and balance exercises. They will do 5 minutes warm-up exercises before the session and 5 minutes cool-down exercises as well as breathing exercises at the end of the session and will participate in a 50-minute treatment session in total.

In the control group treatment protocol, patients will follow the 30-minute video exercise practices for the lower and upper extremities that are similar to Nintendo Wii Fit exercises for the control group at home two days a week. exercises will complete the 50-minute training session. Apart from exercise sessions, patients will record their activities (walking, cycling, swimming…) in daily life forms with their own pedometers. Thus, changes in physical activity levels will be monitored.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Virtual Reality and Video Assisted Exercises in Pediatric Chronic Kidney Disease.
Actual Study Start Date : July 30, 2018
Estimated Primary Completion Date : November 28, 2020
Estimated Study Completion Date : December 28, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study grup-Virtual reality- Nintendo Wii Fit exercise group
in this group patients will complete 12 sessions of virtual reality exercise - Nintendo Wii Fit Plus, 30-minute training sessions with strengthening exercises for the lower extremities and upper extremities, aerobic and balance exercises, two days a week. They will do 5 minute warm-up exercises before stretching, stretching exercises and 5 minute cooling exercises at the end of the session, as well as breathing exercises and will attend a total of 50 minutes of treatment.
Other: study group
The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises)
Other Name: virtual reality based therapy -aerobic exercises, stretching exercises

Active Comparator: control group-home based video exercise group
Patients will be join home based exercises two days a week during 12 sessions .we will prepare for the lower and upper extremity features similar to Nintendo Wii Fit exercises 30 minutes of video game exercise practices, 5 minutes warm-up exercises, 5 minutes cooling exercises and complete the 50-minute training session with the breathing exercises we will teach them. In addition to exercise sessions, patients will record their activities (walking, cycling, swimming ına) in daily life schedules with their pedometers. Thus, changes in physical activity levels will be monitored.
Other: control group
The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises
Other Name: home based video exercise group




Primary Outcome Measures :
  1. Muscle strength [ Time Frame: 6 Weeks ]
    The strength of the lower and upper extremity muscles is measured with a digital dynamometer.

  2. Lung Parameters- Forced vital capacity (FVC), forced expiratory volume 1 second (FEV1), peak expiratory flow (PEF) and FEV1 / FVC [ Time Frame: 6 Weeks ]
    Lung Parameters are measured after 3 repetitive treatments performed by using a digital spirometer.Forced vital capacity (FVC), forced expiratory volume 1 second (FEV1), peak expiratory flow (PEF) and FEV1 / FVC ratio is measured by using a digital spirometer.

  3. Inflammation value [ Time Frame: 6 weeks ]
    The inflammation level of the patients is evaluated at the beginning and at the end of 6 weeks by looking at the patient's routine blood test results (c reactive protein or sedimentation).


Secondary Outcome Measures :
  1. Fatigue [ Time Frame: 6 Weeks ]
    The fatigue parameter is evaluated with the Pediatric Quality of Life Inventory Version 4.0 General Scales (PedsQL), a tool developed specifically to assess the physical, school, emotional, and social domains of health-related quality of life in children previously confirmed in healthy and patient populations. From the physical area of PedsQL individual elements of low energy level will be extracted from both child and parent questionnaires to assess the prevalence of fatigue. The frequency of low energy over the past month is classified as one of four categories: "never"; "hardly"; "sometimes"; "Often / almost always". Overall PedsQL scores, from 0 to 100, higher scores mean better quality of life. PedsQL is scored from the "low energy" item from both parents and child surveys.

  2. Quality of life measure [ Time Frame: 6 Weeks ]
    PedsQLTM 4.0 Quality of Life Scale for Children is used to assess the quality of life of children. PedsQLTM 4.0, with a child / adolescent report and primary caregiver report, is a modular approach to measuring health-related quality of life in healthy children and adolescents in confirmed acute and chronic health conditions in Brazil. The questionnaire evaluates four scales (physical, emotional, social and school functioning) in 23 questions using age-specific forms. Self-report forms are available for children / adolescents aged 5-7, 8-12 or 13-18. Parental reports are available for children aged 2-4, 5-7, 8-12 or 13-18. The questionnaire score ranges from zero to 100 on each scale, and higher values are interpreted to indicate a better quality of life.

  3. Functional Capacity-6-Minute Walking Test [ Time Frame: 6 Weeks ]
    Functional capacity is assessed by 6 minute walk test at the baseline and after 6 weeks treatment.

  4. Participation [ Time Frame: 6 Weeks ]

    Participation in the activity is assessed by Scope questionnaire.The Short Child Roller activities and tasks profile (SCOPE) test is a children-specific assessment test. SCOPE is a test that can be used in the age range from birth to 21 years, which evaluates activity participation as person-centered. SCOPE allows the assessment of participation with comparable objective data within the physical, mental and social disabilities of the child. This questionnaire consists of 25 questions and includes 4 questions from the areas of will, habits, interaction and communication skills, processing skills and motor skill activity performance, and 5 questions for the latest environment. High scores indicate good results.

    Children's participation in the activity and their level of entertainment depending on the activity; Short Child Roles Activities and Tasks Profile SCOPE Will and Habits are evaluated by comparing the scores of performance titles before and after treatment.




Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6-18 years of age
  • to be chronic kidney disease,
  • to have chronic kidney disease at least 6 months
  • to have no visual hearing impairment

Exclusion Criteria:

  • Attending another exercise program,
  • to have severe infection (sepsis, peritonitis)
  • Having anorexia or other growth retardation,
  • Mental retardation,
  • Inadequate communication in Turkish,
  • Failure to communicate,
  • Cardiomyopathy,
  • presence of angina pectoris,
  • Standing and walking obstacle
  • Presence of orthopedic problem
  • Cerebrovascular disease
  • Patients with lower limb amputation and not using orthosis-prosthesis,
  • patients with metastatic carcinoma will not be included in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010981


Contacts
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Contact: Irmak Çavuşoğlu, MSc +905346028050 irmak.cavusoglu@acibadem.edu.tr
Contact: Devrim Tarakci, Ass.Prof. +905322052282 dtarakci@medipol.edu.tr

Locations
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Turkey
Istanbul University of Health Sciences Kanuni Sultan Süleyman Training and research Hospital Recruiting
Istanbul, Küçükçekmece, Turkey, 34752
Contact: Sevgi YAVUZ, ASSOC. PROF         
Sponsors and Collaborators
Acibadem University
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Responsible Party: Irmak ÇAVUŞOĞLU, Principal Investigator, Acibadem University
ClinicalTrials.gov Identifier: NCT04010981    
Other Study ID Numbers: 10840098-604.01.01-E.30224
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Irmak ÇAVUŞOĞLU, Acibadem University:
Pediatric Chronic Kidney Disease,
virtual reality
physical therapy
exercise
Nintendo wii
Video based exercise
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency